MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL 20MM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	7207323
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the loop was broken.No patient injury or other complications were reported.Back-up device was available to complete the surgery.Delay greater than 30 minutes was reported.
Additional Manufacturer Narrative
One (b)(4) 20mm continuous loop endobutton returned.The complaint stated: ¿during the surgery the loop was broken.¿ the complaint was visually confirmed.The loop has been severed across all fibers.The product was used.Due to the nature of the textile filaments being extremely fine, finesse and care with handling is necessary.The anchor component is quite damaged.The condition is consistent with being nicked and gouged with another particularly sharp instrument such as the related drill.This would easily sever the filaments as well.No root cause related to the manufacturing process was confirmed.

• Brand Name: ENDOBUTTON CL 20MM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8593063
• Report Number: 1219602-2019-00523
• Device Sequence Number: 16717707
• Product Code: GAT
• UDI-Device Identifier: 03596010388278
• UDI-Public: 03596010388278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 7207323
• Device Lot Number: 50573477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR